Exercise in Patients Admitted With Recently Decompensated Heart Failure
- Conditions
- Functional Cardiac DisorderDecompensated Heart Failure
- Interventions
- Procedure: ERIC protocol
- Registration Number
- NCT03838003
- Lead Sponsor
- Universidade do Porto
- Brief Summary
An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.
- Detailed Description
With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity.
Patients in the test group may start the program only on stage I or II according to clinical criteria. At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- Admission diagnosis of Decompensated heart failure
- More than 18 years old
- Capacity to provide informed consent
- Osteoarticular pathology that impedes the performance of the exercise
- Existence of inotropic infusions
- Dysrhythmia or precordial pain in the last 24 hours
- Acute pulmonary edema in the last 12 hours
- Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient)
- Need for oxygen at a rate greater than 3 /min
- Glycemic decompensation in the last 12 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Training group ERIC protocol Patients admitted due to decompensated heart failure who will perform the training protocol - ERIC protocol
- Primary Outcome Measures
Name Time Method 6 minute walking test through study completion, an average of 1 year Number of meters walked in the 6 minute walking test
- Secondary Outcome Measures
Name Time Method Number of dysrhythmias during exercise in the training group through study completion, an average of 1 year To quantify the number of dysrhythmias during exercise in the training group
Number of falls during exercise in the training group through study completion, an average of 1 year To quantify the number of falls during exercise in the training group
Number of chest pain situations during exercise in the training group through study completion, an average of 1 year To quantify the chest pain situations during exercise in the training group
Barthel Index score through study completion, an average of 1 year Barthel evaluates dependence on self-care
London Chest Activity of Daily Living (LCADL) scale score through study completion, an average of 1 year LIDL accesses how dyspnea affects self-care
Number of emergency situations during exercise in the training group through study completion, an average of 1 year To quantify the number of emergency situations during exercise in the training group
Trial Locations
- Locations (1)
Centro Hospitalar do Porto
🇵🇹Oporto, Portugal